跳至主要内容
临床试验/NCT01375621
NCT01375621已完成不适用

Epidemiology of Rural MRSA : Is Livestock Contact a Risk Factor?

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 1,342 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,342
试验地点
1
主要终点
Epidemiology of MRSA in AHS cohort

研究概览

简要总结

Background:

  • MRSA is a type of bacteria that causes serious health problems. It can cause severe infections and is difficult to treat. MRSA has been found in a high number of people who work with some kinds of livestock, such as pigs. Researchers want to study people in rural areas, where more people work with or around livestock. They want to see if MRSA is more common or causes more serious infections in these areas.

Objectives:

  • To look at the relationship between livestock handling (especially pigs) and MRSA bacteria in people in rural areas.

Eligibility:

  • Participants in the Agricultural Health Study in Iowa, including those who are exposed to livestock.
  • Healthy volunteers who are not exposed to livestock.

Design:

  • This study requires an initial visit and monthly follow-up surveys for 18 months.
  • At the first visit, participants will have throat and nose swabs to collect cell and bacteria samples. They will also complete a questionnaire about their health habits. Other questions will ask about any work that brings them into contact with livestock like cows, pigs, or chickens.
  • Every month for the next 17 months, participants will complete another questionnaire to record any changes in their health and livestock contact information. They will also collect throat and nose swabs. They will send the questionnaires and the swabs to the study researchers.
  • Participants will be paid for the first visit and for every monthly survey and swab collection they return.
  • No treatment will be given as part of this protocol.

详细描述

The goal of this study is to understand the epidemiology of antibiotic-resistant S. aureus, including methicillin resistant S. aureus (MRSA), outside of the hospital environment. Our objective is to characterize the epidemiology of S. aureus in the rural community, focusing on persons who have contact with livestock. We will achieve this by carrying out two parallel prospective cohort studies in Iowa, examining 1) individuals enrolled in the Agricultural Health Study, including those who raise swine; and 2) a matched population-based group with no livestock exposure. We will partner with the state s microbiological diagnostic laboratories in order to collect isolates from the symptomatic S. aureus infections. Our central hypothesis is that individuals working in close proximity to livestock and poultry are at risk of occupational exposure to MRSA. We further hypothesize that farmers in contact with livestock (swine in particular) will be more likely to be colonized with swine-associated S. aureus strains than are individuals without contact. Finally, we expect to see both typical human strains of S. aureus (including USA300) as well as animal-associated strains (such as ST398) causing infections in Iowans. Our rationale is that successful completion will provide opportunities to institute an early warning system to evaluate emerging S. aureus strains, allowing for potential interventions prior to widespread dissemination in the human population. We will test our central hypothesis and accomplish the objective of this application by pursuing the following specific aims:

  1. Establish the prevalence, molecular subtypes, and antibiotic resistance profiles of S. aureus in populations of rural Iowans, and determine risk factors for colonization. We hypothesize that individuals in contact with swine will be more likely to carry MRSA than individuals lacking such exposure; that swine workers will more frequently be colonized with swine-associated strains such as ST398; and that S. aureus isolates collected from livestock farmers will more frequently demonstrate resistance to antibiotics including methicillin and tetracyclines than isolates collected from individuals lacking livestock exposure.
  2. Determine the incidence and molecular epidemiology of symptomatic S. aureus infections in rural Iowans. We hypothesize that symptomatic infections will be uncommon in our cohort relative to colonization, and that the majority of such infections will be skin and soft tissue infections. We further hypothesize that the majority of infections in our cohorts and elsewhere in the state will be caused by common strains (including USA300), but that some infections will also be caused by animal-associated strains, including ST398.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Months 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Epidemiology of MRSA in AHS cohort

时间窗: ongoing

Establish the prevalence, molecular subtypes, and antibiotic resistance profiles of S. aureus in populations of rural Iowans, and determine risk factors for colonization.

Epidemiology of MRSA in matched, population-based non-AHS group

时间窗: ongoing

Determine the incidence and molecular epidemiology of symptomatic S. aureus infections in rural Iowans.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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